510(k) K062450 ยท KPS System, Tomography, Computed, Emission
D-SPECT CARDIAC SCANNER SYSTEM
| Applicant | Spectrum Dynamics , Ltd., Kfar Saba, IL |
| Decision | Substantially Equivalent, Oct 20, 2006 |
| Received | Aug 22, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062450
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.